Pharmacokinetic Drug Interactions Between HGP1607 and HGP1501

A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic Drug Interactions and the Safety Between HGP1607 and HGP1501 in Healthy Male Volunteers

A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic drug interactions and the Safety between HGP1607 and HGP1501 in Healthy Male Volunteers

Study Overview

• Status: Completed
• Conditions: Healthy Male Volunteers
• Intervention / Treatment: Drug: HGP1607; Drug: HGP1501; Drug: HGP1607+HGP1501

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul Asan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 1.age 19~40 years
• 2.The result of BMI is not less than 19 kg/m2 , no more than 28 kg/m2
• 3.Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
2. Subjects who judged ineligible by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Seguence 1; Period 1 : HGP1607 Period 2 : HGP1501 Period 3 : HGP1607+HGP1501	Drug: HGP1607; Take it once per period; Drug: HGP1501; Take it once per period; Drug: HGP1607+HGP1501; Take it once per period
EXPERIMENTAL: Seguence 2; Period 1 : HGP1607 Period 2 : HGP1607+HGP1501 Period 3 : HGP1501	Drug: HGP1607; Take it once per period; Drug: HGP1501; Take it once per period; Drug: HGP1607+HGP1501; Take it once per period
EXPERIMENTAL: Seguence 3; Period 1 : HGP1501 Period 2 : HGP1607 Period 3 : HGP1607+HGP1501	Drug: HGP1607; Take it once per period; Drug: HGP1501; Take it once per period; Drug: HGP1607+HGP1501; Take it once per period
EXPERIMENTAL: Seguence 4; Period 1 : HGP1501 Period 2 : HGP1607+HGP1501 Period 3 : HGP1607	Drug: HGP1607; Take it once per period; Drug: HGP1501; Take it once per period; Drug: HGP1607+HGP1501; Take it once per period
EXPERIMENTAL: Seguence 5; Period 1 : HGP1607+HGP1501 Period 2 : HGP1607 Period 3 : HGP1501	Drug: HGP1607; Take it once per period; Drug: HGP1501; Take it once per period; Drug: HGP1607+HGP1501; Take it once per period
EXPERIMENTAL: Seguence 6; Period 1 : HGP1607+HGP1501 Period 2 : HGP1501 Period 3 : HGP1607	Drug: HGP1607; Take it once per period; Drug: HGP1501; Take it once per period; Drug: HGP1607+HGP1501; Take it once per period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUClast of HGP1607	16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
Cmax of HGP1607	16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
baseline corrected AUClast of HGP1501	0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
baseline corrected Cmax of HGP1501	0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h

Secondary Outcome Measures

Outcome Measure	Time Frame
AUCinf of HGP1607	16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
Tmax of HGP1607	16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
T1/2 of HGP1607	16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
AUClast of HGP1501	0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
Cmax of HGP1501	0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
baseline corrected AUCinf of HGP1501	0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
baseline corrected Tmax of HGP1501	0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
baseline corrected T1/2 of HGP1501	0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 31, 2017
• Primary Completion (ACTUAL): May 28, 2017
• Study Completion (ACTUAL): June 16, 2017

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 20, 2017
• First Posted (ACTUAL): March 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HM-BAVI-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No